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Chyle Leak After Pancreatic Operation

Observational Study in Chyle Leak After Pancreatic Operation

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03127150
Enrollment
1000
Registered
2017-04-25
Start date
2018-05-01
Completion date
2021-05-01
Last updated
2017-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

Chylous leakage, Diagnostic criteria, Pancreas surgery, Therapy

Brief summary

With the development of pancreatic surgery, the surgeon has put more emphasis on chylous fistula as the postoperative complications in recent years. The diagnostic criteria and treatment methods about chylous leakage have been developed and improved in clinical practice. However, there remains controversy about the high risk factors and efficient control measures during the perioperative period.

Detailed description

Chylous fistula is one of the common complications after pancreatic operation, whose incidence is about 10%. The delayed diagnosis or wrong treatment in the perioperative period may lead to refractory chylous ascites, water-electrolyte imbalance, malnutrition, immune dysfunction, secondary infection and other complications. In the past, chylous fistula, as the postoperative complication, is common in abdominal aortic surgery, gynecological malignancies accompanied with posterior peritoneum lymphadenectomy and spinal surgery, etc. But chylous fistula after pancreatic operation did not attract enough attention. The comparative study or case analysis is lacked in relevant reports and there is no consensus on diagnostic criteria. In addition, once it occurs after pancreatic operation, the rehabilitation of patients will be affected, increasing the burden of hospitalization and even endangering the lives of patients due to the lack of diagnosis and treatment experience of specialists. The International Study Group of Pancreatic Surgery (ISGPS) proposed relevant definitions under the background of no unified diagnostic criteria of chylous fistula after pancreatic operation. But this definition still has some shortcomings; for example, it lacks the value of clinical guidance and research implementation. Moreover, how to take targeted preventive measures, choose the optimal treatment method and avoid complications, and whether there is a superior treatment method need to be further considered and investigated. Therefore, we performed this study, so as to better improve the relevant definition and provide guidance for the diagnosis and treatment.

Interventions

None listed

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Must have a diagnosis of CL after pancreatic operation * Aged 18 or older * Of either sex

Exclusion criteria

* No specific

Design outcomes

Primary

MeasureTime frameDescription
Chylous fistulaFrom date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 daysThe determine of chylous fistula follows the International Study Group on Pancreatic Fistulas (ISGPF) criteria.

Secondary

MeasureTime frameDescription
Extubation timeFrom date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 daysThe time of removing the drainage tube
Hospital staysFrom date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 daysthe time during the operation to hospital discharge
Number of hospitalizationsFrom date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 daysNumber of hospitalizations during the observational period
MortalityFrom date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 200 daysPostoperative death in 30 days

Countries

China

Contacts

Primary ContactXue-Li Bai, phD
shirleybai57@hotmail.com+86 571 87783510

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026